Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
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ClinicalTrials.gov Identifier: NCT00144573 |
Recruitment Status
:
Completed
First Posted
: September 5, 2005
Last Update Posted
: December 15, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: MRA(Tocilizumab) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

- 20% improvement based on the ACR criteria compared with the baseline value. [ Time Frame: throughout study ]
- Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable. [ Time Frame: Week 0, Week 4 ]

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria
- Patients who are diagnosed with RA according to the 1987 ACR (American College of Rheumatology) classification criteria
- Patients with RA at least 6 months prior to enrollment
- Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min
Exclusion criteria
- Patients with Class IV Steinbrocker functional impairment at enrollment
- Patients who are undergoing dialysis
- Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, and have been receiving treatment with leflunomide, within 12 weeks before treatment with the investigational product

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00144573
Study Director: | Takahiro Kakehi | Chugai Pharmaceutical |
Responsible Party: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00144573 History of Changes |
Other Study ID Numbers: |
MRA221JP |
First Posted: | September 5, 2005 Key Record Dates |
Last Update Posted: | December 15, 2008 |
Last Verified: | December 2008 |
Additional relevant MeSH terms:
Arthritis Arthritis, Rheumatoid Renal Insufficiency Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Kidney Diseases Urologic Diseases |